Measures of cerebral perfusion and cerebral metabolism will be compared between patients with different disease courses of MS and healthy controls.Hereby we wish to answer the following questions:- Are cerebral energymetabolism and cerebral…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
- The difference in measures of cerebral perfusion between the groups of RRMS,
SPMS, PPMS patients and healthy controls.
- The difference in measures of cerebral metabolism (as measured with MR
spectroscopy) between the groups of RRMS, SPMS, PPMS patients and healthy
controls.
- The correlation between measures of cerebral perfusion and cerebral
metabolism in the groups RRMS, SPMS, PPMS and healthy control persons.
Secondary outcome
Secondary endpoints:
- the correlation between clinical measures of disability with measures of
cerebral perfusion
- the correlation of clinical measures of disability with measures of cerebral
metabolism
Background summary
There are two disease courses in multiple sclerosis: (1) a form with relapses
and remissions (relapsing remitting MS) and (2) a chronically progressive
disease course.
Exacerbations are caused by focal inflammatory demyelinating lesions.
Immunomosulatory treatments can reduce the number of relapses to some extent.
The most important underlying mechanism of progression in MS is a diffuse
axonal degeneration. The pathogenesis of this progressive axonal demise is
unknown and there is no treatment for it.
With this study we would like to investigate the role of cerebral perfusion in
the pathogenesis of progression in MS. Therefore we would like to measure brain
metabolism and perfusion in healthy controls and patients with different
disease courses of MS. Metabolism will be measured with 1H and 31P MR
spectroscopy, cerebral perfusion will be measured with dynamic susceptibility
contrast enhanced perfusion MRI.
Study objective
Measures of cerebral perfusion and cerebral metabolism will be compared between
patients with different disease courses of MS and healthy controls.
Hereby we wish to answer the following questions:
- Are cerebral energymetabolism and cerebral perfusion decreased in MS patients
in an early stage of the disease (before the start of the progressive phase)?
- Are metabolism and perfusion of the cerebral white matter related to each
other?
- Are cerebral perfusion and cerebral metabolism related to the degree of
disability as measured with clinical rating scales?
Study design
Exploratory case control study
Study burden and risks
Minimal burden participants:
- one non-invasive neurologic examination
- one MRI study
Hanseplein 1
9713GZ
Nederland
Hanseplein 1
9713GZ
Nederland
Listed location countries
Age
Inclusion criteria
Inclusioncriteria patients:
- age 18-60 years
- diagnosis of multiple sclerosis according to the McDonald-criteria (McDonald et al., 2001).
- written informed consent;Inclusioncriteria controls:
- age eightteen and older
- written informed consent
Exclusion criteria
Exclusioncriteria patients:
- use of systemic corticosteroids in the eight weeks before start of the study
- use of immunomodulating therapies (interferon-ß, glatiramer acetate)
- a history of cerebral pathology other than MS (brain infarct, brain haemorrhage, Parkinson's disease, Alzheimer's disease, cerebral vasculitis, brain absces)
- Diabetes mellitus;Exclusiecriteria controls:
- a history of cerebral pathology (brain infarct, brain haemorrhage, Parkinson's disease, Alzheimer's disease, cerebral vasculitis, brain absces)
- Diabetes mellitus
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL13857.042.06 |